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AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT00659360
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : July 30, 2015
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Fibrosarcoma
Adult Leiomyosarcoma
Adult Liposarcoma
Adult Malignant Fibrous Histiocytoma
Adult Rhabdomyosarcoma
Dermatofibrosarcoma Protuberans
Endometrial Stromal Sarcoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Uterine Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage III Uterine Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Stage IV Uterine Sarcoma
Uterine Carcinosarcoma
Uterine Leiomyosarcoma
Intervention Drug: saracatinib
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I AZD0530
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Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.

saracatinib: Given orally

Period Title: Overall Study
Started 17
Completed 17
Not Completed 0
Arm/Group Title Arm I
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Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.

saracatinib: Given orally

Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants
65
(22 to 79)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  47.1%
>=65 years
9
  52.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
11
  64.7%
Male
6
  35.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 17 participants
United States 8
Canada 9
1.Primary Outcome
Title Disease Control Rate, Defined as the Number of Patients Who Achieved Complete Response, Partial Response or Stable Disease For a Period of More Than 4 Months.
Hide Description Response and progression will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Changes in only the largest diameter (unidimensional measurement) of the tumor lesions; where CR is disappearance of all target lesions, PR is at least 30% decrease in the sum of longest diameter, PD is at least 20% increase in the sum of longest diameter recorded since the treatment started and SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Time Frame Up to 5 years
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
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Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.

saracatinib: Given orally

Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Objective Response Rate
Hide Description Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
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Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.

saracatinib: Given orally

Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: participants
0
3.Secondary Outcome
Title Overall Survival
Hide Description Median was estimated. The Kaplan-Meier method will be used to estimate overall survival estimates.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
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Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.

saracatinib: Given orally

Overall Number of Participants Analyzed 17
Median (95% Confidence Interval)
Unit of Measure: months
16.1
(3.8 to 17.9)
4.Secondary Outcome
Title Stable Disease Rate
Hide Description Achieved stable disease as their best response
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
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Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.

saracatinib: Given orally

Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: participants
2
5.Secondary Outcome
Title Duration of Response
Hide Description

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;

Objective Tumor Response "of more than 4 months" was counted toward the Disease Control Rate.

Time Frame Up to 5 years
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Hide Analysis Population Description
Patients who had partial response, complete response or stable disease
Arm/Group Title Arm I AZD0530
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Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.

saracatinib: Given orally

Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: participants
0
6.Secondary Outcome
Title Time to Disease Progression
Hide Description

The Kaplan-Meier method will be used to estimate time to progression estimates.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
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Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.

saracatinib: Given orally

Overall Number of Participants Analyzed 17
Median (95% Confidence Interval)
Unit of Measure: months
1.7
(1.6 to 3.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I
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Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.

saracatinib: Given orally

All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I
Affected / at Risk (%)
Total   5/17 (29.41%) 
Blood and lymphatic system disorders   
Anemia   2/17 (11.76%) 
General disorders   
Fever   2/17 (11.76%) 
Fatigue   1/17 (5.88%) 
Investigations   
Lymphocyte count decreased   2/17 (11.76%) 
Aspartate aminotransferase increased   1/17 (5.88%) 
Blood bilirubin increased   1/17 (5.88%) 
Metabolism and nutrition disorders   
Hypokalemia   1/17 (5.88%) 
Renal and urinary disorders   
Proteinuria   1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders - Other, specify - unspecified   2/17 (11.76%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I
Affected / at Risk (%)
Total   17/17 (100.00%) 
Blood and lymphatic system disorders   
Anemia   12/17 (70.59%) 
General disorders   
Fatigue   13/17 (76.47%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Margaret Von Mehren
Organization: Cross Cancer Institute
Phone: 215-214-1663
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00659360     History of Changes
Other Study ID Numbers: NCI-2009-01054
PHL-054 ( Other Grant/Funding Number: N01CM62203 )
CDR0000588034 ( Other Grant/Funding Number: N01CM62203 )
PMH-PHL-054 ( Other Grant/Funding Number: N01CM62203 )
N01CM62203 ( U.S. NIH Grant/Contract )
First Submitted: April 15, 2008
First Posted: April 16, 2008
Results First Submitted: June 19, 2014
Results First Posted: July 30, 2015
Last Update Posted: June 29, 2018